Mounjaro & Special DRAP Import Permits: What They Mean for You

With growing interest in Mounjaro (tirzepatide) for diabetes and weight loss, many in Pakistan are asking whether they can legally import or use it, given that it is not fully registered with DRAP (Drug Regulatory Authority of Pakistan). The good news is: there is a legal pathway through s

With growing interest in Mounjaro (tirzepatide) for diabetes and weight loss, many in Pakistan are asking whether they can legally import or use it, given that it is not fully registered with DRAP (Drug Regulatory Authority of Pakistan). The good news is: there is a legal pathway through special import permits / No Objection Certificates (NOCs) by DRAP. But there are rules, requirements, and risks. Here’s what you must know.


What is a DRAP “Special Permission” / NOC?

  • Under Pakistani drug regulation, any therapeutic good (medicines, biologicals) generally must be registered with DRAP to import, sell, or distribute. Unregistered drugs are those not yet formally approved for registration.

  • Special Permissions or NOCs are authorizations granted by DRAP to import unregistered therapeutic goods under certain conditions:

    1. For personal use (patient/prescribed by a doctor.

    2. For hospitals / medical institutions to use medicines not available locally or not yet registered.

    3. As part of an exemption policy for essential, lifesaving drugs or “innovative therapies” which are unregistered but deemed critical for public health.

  • DRAP’s “Special Permissions” page outlines how one can apply for import/export of unregistered therapeutic goods either for personal use, institutional use, donations, or trial/sample imports.


Recent Legal Changes & Exemptions

  • In August 2025, the Federal Government extended an exemption allowing hospitals and institutions to import certain unregistered “lifesaving drugs” (anti‑cancer, cardiac, etc.) under specific conditions.

  • This exemption is grounded in provisions of the Drugs Act 1976 (e.g., Section 36) which allow government to exempt certain drugs or classes from parts of the law if public interest requires.

  • Under this exemption:
      • The drug must be not registered locally but essential or lifesaving.
      • Import must be done by hospitals / institutions (not for retail sale) or for therapeutic use.
      • Drugs cannot be sold commercially in general market; usage must be under supervision and for defined therapeutic purAlso, DRAP has made the process for obtaining NOCs or special import permissions more accessible via online portals for personal use, institutional use.


What This Means Specifically for Mounjaro Users / Potential Buyers

If you are considering Mounjaro in Pakistan, here are the implications of the special DRAP permits for you:

  1. It may be possible to legally import Mounjaro for personal use.
    If a doctor prescribes it and it is not registered in Pakistan, you can apply for DRAP's NOC for personal import. You’ll need documentation—prescription, identity, details of the drug (name, manufacturer, strength). (Similar procedure has been in place historically for unregistered meds.

  2. Hospitals or clinics may obtain Mounjaro under special import / exemption.
    If they can demonstrate it is essential (no alternatives available, lifesaving/therapeutic necessity), they may import it under the exemption or NOC for unregistered but lifesaving drugs (depending on government’s and DRAP’s current policy).

  3. You must ensure the product is not being sold in retail market illegally.
    The rules generally disallow resale or commercial distribution of unregistered medicines brought in under special import permissions. If someone is offering Mounjaro for retail sale without registration, that may be non‑compliant with DRAP law.

  4. Documentation is critical.
    Having valid prescription, identity, proof of how much medication, what strength, and where it’s coming from, is essential. Also, often you’ll need to show that the drug is freely sold in its country of origin or meets other criteria that DRAP lays out. (Similar to guidance for other unregistered medicines.


How to Apply / What Steps You Need to Take

Here’s a step‑by‑step of what you typically need to do:

StepWhat to Do
1. Get a prescriptionLicensed medical practitioner prescribes Mounjaro, specifying why an unregistered drug is required.
2. Identify drug detailsManufacturer, strength, dosage, batch if possible; country of origin; proof that it is “freely sold” or approved elsewhere (if required).
3. Apply for DRAP NOC / special permissionUse DRAP’s “Special Permissions” portal/process. Fill out application for import of unregistered therapeutic goods for personal use. Include all required documents (CNIC, prescription, drug details).
4. Wait for approvalThe DRAP divisions (QA & LT, Import/Export section) will review application. It may include verifying if drug is unregistered, whether its use is critical, ensuring conditions are met. Time may vary. 1
5. Ensure safe sourcing & transportOnce approved, import from reputable supplier, maintain cold chain, check packaging, batch, expiry.
6. Maintain records & usage under supervisionUsually rules require you (or the hospital) to maintain consumption records under a qualified person, use the drug under medical supervision, possibly with reporting obligations.

Potential Limitations & Things to Be Aware Of

While DRAP’s special permissions open up legal pathways, there are limitations:

  • Time & Bureaucracy: Processing times may vary; delays possible. Having all documents correct speeds things up.

  • Cost: Even with permit/NOC, cost of drug, shipping, import duties/customs (if any), cold storage, etc., still apply.

  • Supply & Authenticity Risks: Even with legal import, you need to ensure the drug is genuine (authorized manufacturer, good packaging, maintained cold chain) to avoid counterfeit or degraded product.

  • Regulatory Changes: Laws, permit requirements, exemptions may change; what is permitted today may be modified. Stay updated through DRAP notices and government publications.

  • Not always for retail sale: Many permissions only allow import/use by individuals or institutions, and may explicitly disallow resale. Using for commercial sale without registration is generally against the law.


FAQs – Special Import Permits in Context of Mounjaro

QuestionAnswer
Can I personally import a box of Mounjaro pens for myself?Possibly yes — if you have a prescription, apply for the NOC under personal use, include proper documentation. But ensure the quantity is reasonable and for personal non-commercial usage.
Do hospitals/clinics legally get Mounjaro under DRAP exemptions?Yes, under certain criteria (essential / lifesaving status, no acceptable alternatives, import via special permission). But hospital must follow DRAP’s conditions.
Will DRAP punish if I buy unregistered Mounjaro without NOC?Using unregistered drugs without proper permit or misuse may violate regulations. Also risk of counterfeit or unsafe product. Legal repercussions could vary.
Does the permit guarantee quality?No. DRAP permit gives legal import status but doesn’t replace the need to verify authenticity, manufacturer, correct storage, etc.

Bottom Line

  • The DRAP special import / NOC system gives a legal and regulated way for individuals or institutions in Pakistan to obtain unregistered drugs like Mounjaro under certain conditions.

  • You need to meet requirements: valid prescription, identity, drug details, and use it under medical supervision.

  • This does not mean Mounjaro is fully registered in Pakistan (so it cannot be freely sold in the market like registered medicines).

  • Always verify authenticity and source. Even with a permit, safety is not automatic.

If you like, I can check whether there has been any recent DRAP notice that specifically mentions Mounjaro/tirzepatide under these special permits (2025‑2026), so you can see up‑to‑date status.


rehankhalid77

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